Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NuCare Pharmaceuticals,Inc.
NuCare Pharmaceuticals,Inc.
010632300
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PHENDIMETRAZINE TARTRATE
Product Details
NDC Product Code
68071-3509Application Number
ANDA040762Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 3, 2024SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
PhendimetrazineActive
Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1